From the Department of Orthopaedic Surgery, LSU Health Sciences Center, New Orleans, LA (Dr. Dasa); the Tucson Orthopaedic Institute, Tucson, AZ (Dr. Skrepnik); the Noble Clinical Research, Tucson, AZ (Dr. Petersen); and the Rubin Institute for Advanced Orthopedics, Center for Joint Preservation and Replacement, Sinai Hospital of Baltimore, Baltimore, MD (Dr. Delanois).
J Am Acad Orthop Surg Glob Res Rev. 2022 Sep 12;6(9). doi: 10.5435/JAAOSGlobal-D-22-00115. eCollection 2022 Sep 1.
Mobile app-based neuromuscular electrical stimulation (NMES) is a promising treatment of knee osteoarthritis as previously demonstrated in a 12-week, randomized, double-blind, sham-controlled, multicenter trial (parent study).
Sixty-four of the 253 patients with knee osteoarthrosis who completed the 12-week parent study were enrolled in a 14-week extension study during which they continued to receive double-blind, home-based NMES (two 20-minute daily sessions, 5 d/wk) with either the original device ("active NMES") or a low-voltage version ("sham NMES"). All subjects who enrolled in the extension study comprised the intent-to-treat population and subjects who applied NMES (compliance monitored through the mobile app and a remote portal) for at least 2,800 minutes (14-week device usage) comprised the per-protocol therapy compliant population.
In the per-protocol therapy compliant population, the active NMES group (n = 21) had a higher reduction in Visual Analog Scale Nominated Activity (64.7% versus 24.3%, P = 0.020) and Visual Analog Scale Nominated Activity improvement ≥50% (76.2% versus 12.5%, P = 0.002) than the sham NMES group (n = 8). Outcomes were not markedly different between groups in the intent-to-treat population.
Applying NMES therapy for an additional 14 weeks (totaling 26 weeks) resulted in notable and clinically meaningful pain relief when patients were fully compliant with NMES.
基于移动应用的神经肌肉电刺激（NMES）是一种有前途的膝骨关节炎治疗方法，这在前一项为期 12 周、随机、双盲、假对照、多中心试验（母研究）中得到了证实。
在完成 12 周母研究的 253 例膝骨关节炎患者中，有 64 例患者入组了为期 14 周的扩展研究，在此期间，他们继续接受双盲、家庭 NMES（每天两次，每次 20 分钟，每周 5 天）治疗，使用的设备为原始设备（“主动 NMES”）或低电压版本（“假 NMES”）。所有入组扩展研究的患者均为意向治疗人群，至少应用 NMES 2800 分钟（14 周设备使用）的患者为符合方案治疗人群。
在符合方案治疗人群中，主动 NMES 组（n = 21）的视觉模拟量表命名活动（64.7%对 24.3%，P = 0.020）和视觉模拟量表命名活动改善≥50%（76.2%对 12.5%，P = 0.002）的降低幅度明显大于假 NMES 组（n = 8）。意向治疗人群中两组间的结果无明显差异。
当患者完全符合 NMES 治疗时，额外应用 NMES 治疗 14 周（总计 26 周）可显著缓解疼痛，且具有临床意义。
